Effects of Maintaining Steady Albumin Levels (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites

NCT04058613 | Unknown

• 1 other identifier: ILBS-TAT4-01
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (\<2.8g/dl) with ascites.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups

  1 year survival

  12 months

Secondary Outcomes (11)

• New onset refractory ascites in both the groups

  12 months

• Spontaneous bacterial peritonitis [SBP] in both groups

  12 months

• Renal impairment in both groups

  12 months

• Hepatorenal Syndrome in both groups

  12 months

• Hepatic encephalopathy grade 3 or 4 in both groups

  12 months

Study Arms (2)

Albumin

EXPERIMENTAL

Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy

Drug: ALB Protein, Human

Placebo

PLACEBO COMPARATOR

Placebo

Other: placebo

Interventions

ALB Protein, Human DRUG

Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy

Albumin

placebo OTHER

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly detected cirrhotic patients aged more than 18 years
• Cirrhosis defined by standard clinical, analytical and/or histological criteria
• Serum albumin level \< 2.8g/dl with or without ascites
• Who would agree to give written informed consent

You may not qualify if:

• Uncontrolled HTN (sys\>150/ dis \>90 mmHg) or h/o any drug therapy for HTN
• Prior h/o Transjugular Intrahepatic Portosystemic Shunt (TIPS)
• Hepatocellular Carcinoma
• Active alcohol abuse within 3 months
• Patients presenting as Acute on Chronic Liver Failure
• Extrahepatic organ failure
• Known case of chronic heart failure or respiratory failure
• Diagnosed Chronic Kidney Disease
• Patients with hydrothorax
• Prior liver transplant recipient
• Human Immunodeficiency Virus infection
• Use of albumin infusion in the last one month
• CTP\>12, MELD\>28
• Total Bilirubin \>3 g/dl
• Overt Hepatic Encephalopathy at Presentation

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

ALB protein, human

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Shasthry SM, MD

CONTACT

01146300000; shasthry@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: September 10, 2019
• Primary Completion: August 8, 2020
• Study Completion: August 8, 2021
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

IN (1)